FDA 510(k)

MyLabX75 6430, MyLab XPro75 6430

N.º K: K212021 · 2021-09-16

Fecha de decisión2021-09-16

Código de productoIYN

Comité asesorRA

DecisiónSubstantially Equivalent

Resumen del dispositivo

6430 MyLabX75, 6430 MyLab XPro75 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2021-09-16 under 510(k) number K212021. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the 6430 MyLabX75, 6430 MyLab XPro75?

6430 MyLabX75, 6430 MyLab XPro75 is a medical device that received FDA 510(k) clearance on 2021-09-16. The listed applicant is Esaote, S.p.A.. The 510(k) number is K212021.

When did 6430 MyLabX75, 6430 MyLab XPro75 receive FDA 510(k) clearance?

6430 MyLabX75, 6430 MyLab XPro75 received FDA 510(k) clearance on 2021-09-16, under 510(k) number K212021.

Who is the listed applicant for 6430 MyLabX75, 6430 MyLab XPro75?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 6430 MyLabX75, 6430 MyLab XPro75?

The FDA product code for 6430 MyLabX75, 6430 MyLab XPro75 is IYN.

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Otros registros que enlistan a Esaote, S.p.A. como solicitante

K261331I-Genius (100019400)K253288Sistema de Ultrasonido 6450 (MyLabE80); Sistema de Ultrasonido 6450 (MyLabE85)K260746S-scan Open (100001800)K251901Magnifico Open (100009900)K253310Sistema de Ultrasonido 7600 (MyLabC25); Sistema de Ultrasonido 7600 (MyLabC30)K243253Sistema de Ultrasonido 6600 (MyLabA50); Sistema de Ultrasonido 6600 (MyLabA70)

Ver todos los 25 dispositivos →

Dispositivos relacionados (Código: IYN)

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.